Opportunity Listing - Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Agency: Food and Drug Administration

Assistance Listings: 93.103 -- Food and Drug Administration Research

Last Updated: July 11, 2025

Description

The purpose of this Notice of Funding Opportunity (NOFO) is to fund clinical trials of products evaluating efficacy and/or safety in support of a new indication or change in labeling to address unmet needs in rare diseases or conditions. Additionally, through the funding of collaborative, efficient, and/or innovative clinical trials, FDA expects to increase the number of approved treatments for rare diseases and exert a broad and positive impact on rare disease drug development.

Eligibility

Eligible applicants

Miscellaneous

Other

Additional information

Eligible OrganizationsHigher Education InstitutionsPublic/State Controlled Institutions of Higher EducationPrivate Institutions of Higher EducationNonprofits Other Than Institutions of Higher EducationNonprofits with 501(c)(3) IRS Status (Other than Institutions of Higher Education)Nonprofits without 501(c)(3) IRS Status (Other than Institutions of Higher Education)For-Profit OrganizationsSmall BusinessesFor-Profit Organizations (Other than Small Businesses)Local GovernmentsState GovernmentsCounty GovernmentsCity or Township GovernmentsSpecial District GovernmentsIndian/Native American Tribal Governments (Federally Recognized)Indian/Native American Tribal Governments (Other than Federally Recognized)Federal Governments U.S. Territory or PossessionOtherIndependent School DistrictsPublic Housing Authorities/Indian Housing AuthoritiesNative American Tribal Organizations (other than Federally recognized tribal governments)Faith-based or Community-based OrganizationsRegional OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations)Foreign OrganizationsNon-domestic (non-U.S.) Entities (Foreign Organizations) are eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are allowed.

Grantor contact information

Description

Kimberly Pendleton Chief Grants Management Officer

Email

Email: Kimberly.Pendleton@fda.hhs.gov

Kimberly.Pendleton@fda.hhs.gov

Documents

No documents are currently available.

Link to additional information

RFA-FD-25-020 Reissue of RFA-FD-23-001- Clinical Studies of Orphan Products Addressing Unmet Needs of Rare Diseases (R01 Clinical Trials Required)

Closing: May 16, 2028

Application process

This site is a work in progress. Go to www.grants.gov to apply, track application status, and subscribe to updates.

Award

$--

Program Funding

Expected awards

$--

Award Minimum

$900,000

Award Maximum

Funding opportunity number:

RFA-FD-25-020

Cost sharing or matching requirement:

Funding instrument type:

Grant

Opportunity Category:

Discretionary

Opportunity Category Explanation:

Category of Funding Activity:

Agriculture

Consumer protection

Food and nutrition

Category Explanation:

History

Version:

Posted date:

July 11, 2025

Archive date:

June 15, 2028